INSIGNIA

Bracket, Plastic, Orthodontic

ORMCO CORP.

The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Insignia.

Pre-market Notification Details

• Device ID: K121524
• 510k Number: K121524
• Device Name: INSIGNIA
• Classification: Bracket, Plastic, Orthodontic
• Applicant: ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867
• Contact: Wendy Garman
• Correspondent: Wendy Garman; ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867
• Product Code: DYW
• Subsequent Product Code: EJF
• Subsequent Product Code: NJM
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-23
• Decision Date: 2012-08-09
• Summary: summary